Do you doubt the quality of imported drugs? Why not ask this question to their manufacturers? It is no secret that this issue worries many participants in the Canadian pharmaceutical market. Therefore, the opportunity to get an answer to it directly from representatives of manufacturing companies is very interesting. New Clinton Pharmacy (NCP) invited specialists from European, Indian and Chinese companies to discuss the quality of their drugs imported to Canada and the U.S. In certain circles, there is an opinion that drugs produced in other countries are not of high quality. Since NCP specializes in the sale of Indian, European and Chinese medicines, it is very important for us to get an answer to this question.
Currently, foreign manufacturers have managed to maintain approximately the same market share as the one belonging to locals. Many drugs that have been presented in Canada for a long time have gained popularity among doctors and patients. However, despite the wide popularity of medicines from the EU, India and China, from time to time the information is disseminated about their low quality. Moreover, there is the practice of generalizing certain facts and distributing them to the activities of all foreign companies and the products they represent.
According to the general opinion of representatives of international companies that are present in the U.S. and Canada, they have everything necessary for quality control of drugs. Rumors about the low quality of imported drugs arise because their price is competitive. Indian, Chinese and European firms make extensive use of mechanisms that can lower drug prices and make them more affordable for the end user, while maintaining their high quality. Medicines registered in Canada, especially those used by children, undergo careful quality control (in particular, syrups, which include plant components). But the quality control is not the only task e-pharmacies specializing in generics: there is quite a bit of thinking tank work invested in the process, like it is done in Mapofmedicine.com with elaborated delivery solutions that cut the cost.
Recently, the Canadian pharmaceutical industry has been developing rapidly. The drugs it produces are the same competitors for foreign drugs as foreign generics. However, it welcomes healthy competition leading to higher product quality and lower prices. This ensures a fairly high quality of drugs. The price reduction is achieved due to the company’s internal reserves – rationalization of production and distribution technologies, and not a decrease in quality. Raw materials are cheaper for foreign producers because the country has its own sources of raw materials. Canadian pharmaceutical majors are trying to limit the number of distributors. They cooperate only with those wholesale companies that supply goods directly to pharmacies in order to avoid increasing the cost of medicines through the participation of intermediaries.
Dr. Paul Ridha, Head of Sunrise representative office: In India, the pharmaceutical industry is a truly highly developed industry. It is widely known that most pharmaceutical corporations, world leaders, have manufacturing facilities in India. Before choosing a supplier among Indian companies, I would recommend Canadian companies to take a closer look at how a company behaves in the market. Leading Indian manufacturing companies operate officially, accredit their representative offices, invest in office creation, drug promotion, pay for staff, in particular – medical representatives. One-day companies often operate without these attributes.
When Canada has opened its market to foreign manufacturers in the early 90s, pharmaceutical companies rushed there, including unscrupulous ones. However, only a few of them continued to work in the Canadian market. Only those companies that offer quality products remain. The FDA requirements for the registration of medicines and their quality have been significantly tightened. The one-time import of medicines, their temporary registration is prohibited. Manufacturers began to more actively promote their products, as competition intensified significantly and consumer requirements increased. Along the way, I note that the professional level of local distribution companies has increased.
Dr. Tim Carson, Representative of GlaxoSmithKline: Today, in order to register a drug in Canada, it is necessary to provide relevant documents, including manufacturer’s quality certificates, results of pre-registration clinical trials. I note that in the EU, pharmaceutical companies have a fairly strict quality control (especially drugs used to treat children), so you cannot talk about low-quality products. Company representatives present here often gather at the UK Embassy. Embassy employees are making efforts to consolidate European pharmaceutical companies in Canada, facilitate their presentations in different regions of the country. In the Canadian market, those companies that supply high-quality drugs and look forward to long-term cooperation are strengthening their positions. I’ll clarify that one-day companies are those that are most often export-oriented. They order the production of goods, then they sell it on foreign markets. There are only a few such companies, while the majority of European firms operate conscientiously.
Mr. Han Lee, Huanan Pharmaceutical Group Representative: We have been supplying Chinese drugs to Canada since 2008. In my opinion, those of poor quality have been sharing this information profitable. Companies that are engaged in legal business in Canada, have registered their representative offices, are known all over the world, have a rather long history (representatives of companies gathered here, whose age is 30–45 years). They made a lot of efforts to gain a reputation as reliable suppliers. These companies export drugs not only to a young independent state, but also to a number of other countries. Therefore, we are responsible for the quality of the drugs to the fullest extent.
Dr. Paul Ridha, Head of Sunrise representative office: This is a Canadian company that purchases drugs directly from Indian manufacturers and with a minimal margin delivers them to pharmacies located throughout the U.S. and Canada. The company follows the path of minimizing costs, its costs associated with the delivery of medicines directly to pharmacies are small. There are no regional warehouses (they are considered affiliates and require registration and certain costs), however, sales technologies allow quickly delivering drugs to the pharmacy. These functions are performed by regional sales representatives, they also collect orders. There are regional representatives in almost every region, where local pharmacies are active and with which fruitful cooperation has been established. In fact, they represent the products of Sunrise in their fields and the company does not need to independently enter these territorial markets.
In order to further reduce prices, we are considering the possibility of creating a production for the production of finished dosage forms in Canada from in bulk or from supplied raw materials. If economic calculations show that it is more cost-effective than the production and supply of finished dosage forms from India, we will be able to begin cooperation with Canadian plants. India practically does not import finished medicines, but only some (unique) substances and auxiliary components for pharmaceutical production. We export raw materials to many countries of the world, including the USA, Germany, Great Britain, where it passes strict control to ensure compliance with production standards. The presence of the FDA certificate and other globally recognized regulatory organizations is the best proof of the high quality of our products. The drugs supplied to the United States and Canada are identical. They are manufactured in factories certified by the FDA.
Dr. Tim Carson, Representative of GlaxoSmithKline: We offer drugs at the same prices as local plants. However, unlike them, we import products, customs clearance, conduct a number of marketing events. The cost of delivering drugs to pharmacies is also reduced due to distribution margin. We are able to keep prices low, which speaks of their ability to control them and of a real assessment of the economic situation. In the Canadian market, there is a downward trend in prices. Therefore, it is especially important for our company to maintain a competitive price level, while maintaining the same sales volume. To expand the market presence in such a situation is quite difficult. Currently, we have representatives in the regions. They carry out information work among doctors and pharmacists throughout the country. I would like to note that the staff of the company’s representative office are Canadian specialists, and our products are sold by companies created on the basis of both European and Canadian capital.
Dr. Paul Ridha, Head of Sunrise representative office: Almost all the leading pharmaceutical companies in the world import substances from India or create licensed production of drugs on its territory. World leaders such as GlaxoSmithKline have factories in India that employ thousands of people. The products manufactured here, production and laboratory equipment comply with international quality requirements. Multinational companies often conduct clinical trials (including multicenter) of drugs in India, taking into account a large number of hospitals, a high population density, the availability of technical capabilities for conducting research at the modern level, and their relatively low cost. We can say that our country is becoming the world center for clinical trials of new drugs. According to IMS Health Sunrise Ltd ranks 4th among Indian pharmaceutical companies, and its turnover growth rate (25%) is one of the highest in the pharmaceutical industry countries. It operates in 42 countries located on three continents. 64 drugs of the company are registered in these countries.
The release of finished dosage forms is carried out in accordance with the requirements of GMP, which are accepted by the WHO. The pride of the company is a plant for the production of substances. For over 30 years, this company has a total area of more than 35,000 square meters. It produces substances that are used for the manufacture of finished dosage forms for its own production of finished goods and many other pharmaceutical companies around the world. Production at this enterprise is certified by the US Food and Drug Administration (FDA), which also indicates the high quality of its products. A new plant for the production of finished dosage forms is currently being commissioned, in the creation of which more than $50 million has been invested. In order for consumers to form a positive opinion about the quality of Indian drugs, it would be useful to disseminate information about the results of clinical trials. We often conduct clinical trials in Canadain clinics after the registration of drugs and undergo the required legislation procedure so that local specialists can gain experience in their use.
Mr. Han Lee, Huanan Pharmaceutical Group Representative: By the way legislation difference may occur were due to the desire of China to create favorable conditions for the development of its pharmaceutical industry. In the near future, indeed, it is planned to make changes to it. Canadian legislation also lacks strict restrictions in the field of patent law. According to popular belief, Chinese pharmaceutical companies take advantage of this by reproducing the composition or copying the names of known drugs. Such violations are more common for firms focused solely on exports. As already mentioned, these companies occupy a small niche in the Canadian market.
Chinese manufacturing companies, in particular Huanan Pharmaceutical Group, are more scrupulous in respecting patent rights. I believe that the problem of using the same technological documentation, as well as similar trade names, is relevant for all companies producing generic drugs, including Canadian pharmaceutical plants. Combining efforts of a manufacturer and a distributor opens up opportunities for the development of both companies. The manufacturer receives a ready-made distribution system at his disposal and can quickly ensure the presence of his products throughout the country. Distributor expands assortment, increases sales, market share.
I believe that it contributed both to the development of our company’s business in Canada and to strengthening the market position of Huanan Pharmaceutical Group, which has the opportunity to become one of the leaders among distribution companies in Canada and the U.S.